PHARMACEUTICAL TECHNOLOGY REPORT. Abstract Summary. Introduction. Experimental Methods. Consumer Specialties ashland.com
|
|
- Osborn Jennings
- 5 years ago
- Views:
Transcription
1 PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR (Supersedes PTR-037-2) Page 1 of 7 Hydrodynamic Robustness of Hypromellose and Hydroxypropyl Cellulose Based Modified Release Matrix Systems D. Tewari, R. K. Lewis, W. W. Harcum and T. Dürig Abstract Summary Factors impacting the hydrodynamic robustness of hypromellose and hydroxypropylcellulose matrix systems were investigated using the USP III reciprocating apparatus. Drug release from systems with low (10%) polymer level, low drug solubility or erosion dependent release mechanisms were generally found to vary significantly with change in hydrodynamics. Introduction Recent studies indicate that the USP I (basket) and USP II (paddle) apparatus are often poorly predictive of in vivo release profiles, especially during the fed state, when a dosage form may be retained for 4-6 hours in the stomach, while continuously subjected to 3 to 4 contractions per minute. In contrast, the unconventional method of testing the modified release matrix tablets in the more hydrodynamically aggressive USP disintegration test was highly predictive of in vivo behavior (1). Hypromellose (HPMC) and hydroxypropyl cellulose (HPC) are widely used hydrophilic matrix polymers, however most published data on systems utilizing these two polymers is based on the conventional USP I or II dissolution apparatus. The current study aims to evaluate hydrodynamic robustness of HPMC and HPC matrix systems, taking polymer level, polymer molecular weight (MW) and drug solubility into account. As the disintegration test is not well suited for precise drug release studies on individual tablets, we chose the closely related USP III reciprocating cylinder dissolution apparatus. A variety of hydrodynamic conditions including the high shear, high fluid flow conditions of the disintegration test (as a model of fed state hydrodynamic conditions) as well as lower shear environments, more reflective of fasted state and intestinal hydrodynamic conditions were simulated by varying the reciprocation rate at 5, 15 and 25 dips per minute (dpm). Dissolution behavior in USP Apparatus I (basket) at 100 RPM was used as the reference and compared to USP Apparatus III at 5, 15 and 25 dips per minute (DPM), using the f2 similarity factor. Profiles with f2 values >50 are generally regarded as similar. Experimental Methods Table 1 lists the HPMC Type 2208 and HPC grades studied. Each polymer type was studied at two MW levels spanning intermediate ( kda) to high MW ( kda). Polymer loading was 10 and 30%. The model drugs were soluble theophylline (THEO, solubility 6.9mg/ml in ph 6.8 buffer at 37 C) and low soluble glipizide (GLIP, solubility 1.8 mg/ ml at ph 7.5 with 0.5% polysorbate 80 at 37 C). 400 mg Tablets comprising 25% drug (THEO or GLIP), 30% or 10% polymer (2 polymers at 2 molecular weights each), 0.5% magnesium stearate and q.s. microcrystalline cellulose were prepared by compression on a instrumented rotary tablet press. Hydrodynamic robustness was assessed based on similarity of dissolution profiles under different conditions, lack of erratic release patterns and low variability as measured by maximum standard deviation at individual dissolution time points. All statements, information and data presented herein are believed to be accurate and reliable, but are not to be taken as a guarantee, an express warranty, or an implied warranty of merchantability or fitness for a particular purpose, or representation, express or implied, for which Ashland and its subsidiaries assume legal responsibility. Registered trademark, Ashland or its subsidiaries, registered in various countries. Trademark, Ashland or its subsidiaries, registered in various countries. *Trademark owned by a third party. 2011, Ashland. Rev
2 Page 2 of 7 Table 1. Ashland Pharmaceutical Grade Cellulose Ether Polymers used in this Study. Grade Viscosity (mpa s) Nominal MW (kda) Benecel HPMC K4M PH CR 3,600 (a) 340 Benecel HPMC K100M PH CR 100,000 (a) 1000 Klucel HPC GXF at 2% (b) 370 Klucel HPC HXF at 1% (b) 1150 Results and Discussion (a) Viscosity measured according to EP Monograph (b) Viscosity measured according to USP Monograph General Observations: Factors which predispose a system toward diffusional release and minimize erosional contributions increase the likelihood of achieving a hydrodynamically robust system. These factors include high drug solubility and high gel strength, which can be achieved through increasing polymer MW and polymer loading. In contrast, lower MW and lower polymer loadings and lower drug solubility increase the erosional contributions to total drug release, leading to greater hydrodynamic sensitivity. Soluble Drug Dissolution, 30% Polymer Level: For soluble THEO, the USP I basket apparatus dissolution conditions at 100 rpm were generally similar to the USP III reciprocating cylinder apparatus at 5 dpm. Due to superior gel strength, formulations with 30% high MW HPC and HPMC were the most hydrodynamically robust, with no significant dissolution effect even at 25 dpm (Table 2 and Figures 1 and 2). In these systems drug is primarily released via diffusion through the hydrated gel matrix with negligible matrix erosion. High MW HPC had the longest release duration (t60% hours). For high MW HPMC the t60% values varied form 9-11 hours depending on hydrodynamic conditions. Similarly, THEO formulations comprising 30% medium MW HPC or HPMC were hydro-dynamically robust up to 15 dpm, but release profiles accelerated markedly under extreme shear conditions of 25 dpm (f2 values <50). Figures 3 and 4 illustrate the dissolution behavior of Medium MW HPC and HPMC systems. Soluble Drug Dissolution, 10% Polymer Level: At low polymer levels, high MW HPC is not as effective as HPMC with t60% ranging from hours as opposed to 5-6 hours for HPMC (Table 2 and Figures 1 and 2. At the 10% polymer level the variability of individual tablets increases markedly as hydrodynamic stress increases (Table 3). Low polymer loadings were also problematic for THEO formulations comprising intermediate MW polymer grades. Medium MW HPC was ineffective (t60% <1.5 hours under all dissolution conditions). For medium MW HPMC release times were longer, but extreme hydrodynamic sensitivity even at the lowest reciprocating cylinder frequency of 5 dpm was seen. (Table 3 and Figures 3 and 4). Based on these findings, 10% polymer levels should generally be avoided for soluble drugs. Insoluble Drug Dissolution, 30% level: With the exception of high MW HPC and HPMC at 30%, insoluble GLIP formulations were not as hydrodynamically robust as THEO formulations. However high MW HPMC and HPC at 30% are of limited use due to the physiologically unrealistically long dissolution times (t60%>>24 hours, Table 2). This can be attributed to the fact that erosion is required for GLIP release as diffusion alone is limited by low drug solubility. Medium MW HPC profiles were linear and had low variability under a specific hydrodynamic condition (Figure 5). This was not the case for medium MW HPMC which was more variable and erratic (Figure 6 and Table 3).
3 Page 3 of 7 Insoluble Drug Dissolution, 10% level: High MW HPC GLIP tablets were extremely sensitive to hydrodynamic changes even when switching from USP Apparatus I to USP Apparatus III at 5 dpm. (f2 = 39). 10% High MW HPMC was robust at 5 dpm, but release and variability in individual tablets markedly increased at 15 and 25 dpm. Medium MW HPC was ineffective at 10% polymer levels with t60% ranging from 0.25 to 1 hour ( Tables 2 and 3 and Figures 5 and 6). Conclusion Our study shows that low (10%) polymer levels were generally problematic for both soluble and insoluble drugs, resulting variably in insufficient release retardation, high variability or poor hydrodynamic robustness. At 30% polymer levels, hydrodynamically robust matrix tablets can be achieved for soluble drugs. However it was not possible to achieve hydrodynamic robustness beyond 5 dpm for low soluble, erosion dependent drug matrix systems, while simultaneously achieving release durations less than 24 hours. It is important to select dissolution conditions that provide physiologically relevant levels of shear, especially with respect to fed state conditions. The USP apparatus III set at 15 dpm appears highly suitable for this purpose. References (1) International Patent Application, WO 03/ A1. Louie-Helm, J. and Berner, B. May Table 2. Matrix Polymer, Polymer level and Hydrodynamic Effects on Drug Dissolution MW Polymer Type, Level High HPMC, 30% Medium HPMC, 30% High HPMC, 30% Medium HPMC, 30% T60% (Hrs) USP RPM 5 DPM 15 DPM 25 DPM Theophylline Glipizide >24 >24 >24 > >24 >24 >24 >24 > >24 > <0.25 <0.25 f2 Value (USP I, 100 RPM as Reference) 5 DPM 15 DPM 25 DPM *f2 value in red indicate failure of the dissolution.
4 Page 4 of 7 Table 3. Matrix Polymer, Polymer Level and Hydrodynamic Effects on Variability of Individual Time Points Polymer USP 1 Maximum Standard Deviation MW Type, Level 100 RPM 5 DPM 15 DPM 25 DPM Theophylline High HPMC 30% HPMC 10% HPC 30% HPC 10% Medium HPMC 30% HPMC 10% HPC 30% HPC 10% Glipizide High HPMC 30% HPMC 10% HPC 30% HPC 10% Medium HPMC 30% HPMC 10% HPC 30% HPC 10% *S.D values in red indicate high standard deviation Figure 1. Effect of high MW HPC levels and hydrodynamics on release from soluble theophylline matrix tablets.
5 Page 5 of 7 Figure 2. Effect of high MW HPMC Type 2208 levels and hydrodynamics on release from soluble theophylline matrix tablets. Figure 3. Effect of medium MW HPC levels and hydrodynamics on release from soluble theophylline matrix tablets.
6 Page 6 of 7 Figure 4. Effect of medium MW HPMC levels and hydrodynamics on release from soluble theophylline matrix tablets. Figure 5. Effect of medium MW HPC levels and hydrodynamics on release from insoluble glipizide matrix tablets.
7 Figure 6. Effect of medium MW HPMC levels and hydrodynamics on release from insoluble glipizide matrix tablets. Page 7 of 7
Hydrodynamic Robustness of Hypromellose and Methylcellulose Based Modified Release Matrix Systems D. Tewari, R. K. Lewis, W. W. Harcum and T Dürig
PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-069-1 (Supersedes PTR-069) Page 1 of 8 Hydrodynamic Robustness of Hypromellose and Methylcellulose Based Modified Release Matrix Systems
More informationTable 1 Hydrophilicity of MC and HPMC Grades. Polymer Cloud Point ( C) Hydrophilicity MC HPMC Type 2910 HPMC Type
PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-046-1 (Supersedes PTR-046) Page 1 of 6 Effect of Hypromellose and Methylcellulose Substitution Type, Molecular Weight and Drug Solubility
More informationTo study the effect that hydroxypropylcellulose (HPC) polymer molecular weight (MW) exerts on drug release rates and mechanism from matrix tablets.
PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-029-1 (Supersedes PTR 029) Page 1 of 7 Hydroxypropylcellulose in Modified Release Matrix Systems: Polymer Molecular Weight Controls
More informationPHARMACEUTICAL TECHNOLOGY REPORT. Introduction. Experimental Methods
PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-8 Page 1 of 6 Are Cellulosic Controlled Release Technologies Vulnerable to Dose Dumping in Ethanolic Dissolution Media? Elanor Pinto,
More informationEvaluation of different binders for roller compaction R. Wang, W. Liu, T. Durig
PHARMACEUTICAL THNOLOGY REPORT Consumer Specialties ashland.com PTR 11 Page 1 of 5 Evaluation of different binders for roller compaction R. Wang, W. Liu, T. Durig Objectives When preparing tablets by roller
More informationThe Relevance of USP Methodology in the Development of a Verapamil Hydrochloride (240 mg) Extended Release Formulation
METHOCEL Premium Cellulose Ethers Application Data The Relevance of USP Methodology in the Development of a Verapamil Hydrochloride (240 mg) Extended Release Formulation INTRODUCTION Hydrophilic matrices
More informationEvaluation of Moisture Sorption Methods for Aqueous Moisture Barrier Coatings D. Tewari, R. Lewis, B. Kinsey and T. Dürig*
PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-039-2 (Supersedes PTR-039-1) Page 1 of 9 Evaluation of Moisture Sorption Methods for Aqueous Moisture Barrier Coatings D. Tewari, R.
More informationCONTENTS PAGE. Please note: Preface Matrix system Selection of METOLOSE grades Specifications
Hypromellose CONTENTS PAGE 2 Preface Matrix system Selection of METOLOSE grades Specifications Properties Powder Solution Application Related Patents 3 4-5 6 8 10 13 14 17 Please note: The information
More informationDissolution control of direct compression tablets in different test media using novel pregelatinized starch, Swelstar TM MX-1
Dissolution control of direct compression tablets in different test media using novel pregelatinized starch, Swelstar TM MX-1 ASAHI KASEI CHEMICALS CORPORATION CEOLUS R&D DEPARTMENT 1 CONTENTS General
More informationDVA Symposium Mexico City Anisul Quadir Ph.D, MBA SE Tylose USA, Inc. (A Shin-Etsu Chemical Group Co.) Totowa, NJ
QbD Approach to Formulation of Hydrophilic Matrix Using Sample Kit of Hypromellose [Metolose SR] DVA Symposium Mexico City Anisul Quadir Ph.D, MBA SE Tylose USA, Inc. (A Shin-Etsu Chemical Group Co.) Totowa,
More informationCritical material properties for the design of robust drug products : excipient functionality related characteristics
Critical material properties for the design of robust drug products : excipient functionality related characteristics Dr Liz Meehan, Pharmaceutical Development, Macclesfield UK 1 Excipients Definition
More informationEffect of Excipients on Dissolution: Case Studies with Bio-relevant/ Hydro-alcoholic Media
Effect of Excipients on Dissolution: Case Studies with Bio-relevant/ Hydro-alcoholic Media Sandip B. Tiwari, Ph.D. Technical Director: South Asia Colorcon Asia Pvt. Ltd., Goa, India DISSO-INDIA 2013, May
More informationDirect Compression. With the right ingredients it s a simple, cost-effective manufacturing process
Direct With the right ingredients it s a simple, cost-effective manufacturing process TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Speed and savings sounds good to us
More informationThe Effect of Film Coating and Storage Conditions on the Performance of Metformin HCl 500 mg Extended Release Hypromellose Matrices
METHOCEL Application Data Premium Cellulose Ethers The Effect of Film Coating and Storage Conditions on the Performance of Metformin HCl 500 mg Extended Release Hypromellose Matrices ABSTRACT SUMMARY This
More informationContinuous Granulation Using a Twin-Screw Extruder. Lin Zhu, Ph.D. Manufacture Science and Technology AbbVie June, 2016
Continuous Granulation Using a Twin-Screw Extruder Lin Zhu, Ph.D. Manufacture Science and Technology AbbVie June, 2016 What is a twin screw extruder and how to use it for continuous granulation? Dry feed:
More informationSENTRY TM POLYOX Water Soluble Resins
SENTRY TM POLYOX Water Soluble Resins Technical Information on Stability Introduction Key Points Antioxidants SENTRY POLYOX WSR resins consist of a family of high molecular weight polyethers with nominal
More informationPharma & Food Solutions. POLYOX TM Water Soluble Resins Combining Flexibility with Consistency
Pharma & Food Solutions POLYOX TM Water Soluble Resins Combining Flexibility with Consistency POLYOX 9-13 POLYOX 9-13 POLYOX * are nonionic poly (ethylene oxide) polymers that meet all the specifications
More informationAdopting Technologies to Enhance Quality in Manufacturing
Adopting Technologies to Enhance Quality in Manufacturing Sandip B. Tiwari, Ph.D. March 18, 2012 Current Status of Quality in Pharma Manufacturing Pharmaceutical manufacturing techniques lag behind those
More informationOpadry Enteric. Application Data. Drug Release from Acrylic-Based Opadry Enteric (94 Series) Coated Tablets INTRODUCTION MATERIALS AND METHODS
Opadry Enteric Application Data FORMULATED FOR ORGANIC SOLVENT COATING Drug Release from Acrylic-Based Opadry Enteric (94 Series) Coated Tablets INTRODUCTION The commonly accepted view is that the ph of
More informationFolic Acid in Human Nutrition
Folic Acid in Human Nutrition Folic acid is a water soluble B vitamin widely distributed in foods. Deficiencies lead to impaired cell division and altered protein synthesis. Newborn children of women receiving
More informationFormulation development of Glipizide matrix tablet using different proportion of natural and semi synthetic polymers
Pharm Methods, 2017; 8(1): 45-53 A multifaceted peer reviewed journal in the field of Pharm Analysis and Pharmaceutics www.phmethods.net www.journalonweb.com/phm Research Article Formulation development
More informationA Comparative Evaluation of Cross Linked Starch Urea-A New Polymer and Other Known Polymers for Controlled Release of Diclofenac
Asian Journal of Chemistry Vol. 22, No. 6 (2010), 4239-4244 A Comparative Evaluation of Cross Linked Starch Urea-A New Polymer and Other Known Polymers for Controlled Release of Diclofenac K.P.R. CHOWDARY*
More informationFORMULATION AND DEVELOPMENT OF ER METOPROLAOL SUCCINATE TABLETS
International Journal of PharmTech Research CODEN( USA): IJPRIF ISSN : 0974-4304 Vol.1, No.3, pp 634-638, July-Sept 2009 FORMULATION AND DEVELOPMENT OF ER METOPROLAOL SUCCINATE TABLETS K. Reeta Vijaya
More informationComparative Evaluation of Enteric Film Coatings Applied in Organic Solvents
OPADRY Enteric Acryl-Based Coating System Poster Reprint Comparative Evaluation of Enteric Film Coatings Applied in Organic Solvents PURPOSE Delayed release (DR) film coated products are among the most
More informationOPTIMIZATION OF CONTROLLED RELEASE GASTRORETENTIVE BUOYANT TABLET WITH XANTHAN GUM AND POLYOX WSR 1105
Digest Journal of Nanomaterials and Biostructures Vol. 9, No. 3, July September 2014, p. 1077-1084 OPTIMIZATION OF CONTROLLED RELEASE GASTRORETENTIVE BUOYANT TABLET WITH XANTHAN GUM AND POLYOX WSR 1105
More informationFORMULATION AND EVALUATION OF THEOPHYLLINE BILAYERED TABLETS USING HPC AS MATRIX MATERIAL
INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY Available online at www.ijrpc.com Research Article FORMULATION AND EVALUATION OF THEOPHYLLINE BILAYERED TABLETS USING HPC AS MATRIX MATERIAL
More informationwe ve got you covered pharmaceutical product and solution guide
we ve got you covered pharmaceutical product and solution guide 2 / we ve got you covered Helping to ensure the efficacy, integrity and usability of pharmaceutical formulations At Ashland, our number one
More informationDESIGN AND EVALUATION OF CONTROLLED RELEASE MATRIX TABLETS OF FLURBIPROFEN
Int. J. Chem. Sci.: 10(4), 2012, 2199-2208 ISSN 0972-768X www.sadgurupublications.com DESIGN AND EVALUATION OF CONTROLLED RELEASE MATRIX TABLETS OF FLURBIPROFEN K. V. R. N. S. RAMESH *, B. HEMA KIRNAMAYI
More informationDevelopment of USP Delayed Release Aspirin Tablets using Opadry Enteric, Acrylic-Based Coating System
Opadry Enteric Application Data Acrylic-Based Coating System Development of USP Delayed Release Aspirin Tablets using Opadry Enteric, Acrylic-Based Coating System INTRODUCTION Acetylsalicylic acid (aspirin)
More informationMETOLOSE: CONTENTS PAGE
METOLOSE: CONTENTS PAGE 2 Preface What is Metolose Substitution types Specifications 1) Available grades & viscosity 2) Nomenclature 3) Packaging Characteristics of Metolose Properties of Metolose 1) Powder
More informationInternational Journal of Research in Pharmacy and Science
Research article Available online www.ijrpsonline.com ISSN: 2249 3522 International Journal of Research in Pharmacy and Science Formulation and Evaluation of Floating Tablet of Metoprolol Tartrate Patel
More informationFormulation and Evaluation
Chapter-5 Formulation and Evaluation 5.1 OBJECTIVE After successful taste masking and solubility enhancement of drugs in preliminary studies, by using Mannitol Solid Dispersion, next step includes the
More informationKlucel hydroxypropylcellulose. Physical and chemical properties
Klucel hydroxypropylcellulose Physical and chemical properties 1 2 Table of Contents 1. Introduction...4 2. Chemistry...4 3. Grades and Viscosity Types...................6 4. Physical Properties...........................6.
More informationAvailable Online through Research Article
ISSN: 0975-766X Available Online through Research Article www.ijptonline.com DESIGN AND EVALUATION OF GASTRORETENTIVE TABLETS FOR CONTROLLED DELIVERY OF NORFLOXOCIN Ganesh Kumar Gudas*, Subal Debnath,
More informationSUSTAINED RELEASE TABLETS USING A PVA DC FORMULATION RESISTANT TO ALCOHOL INDUCED DOSE DUMPING
SUSTAINED RELEASE TABLETS USING A PVA DC FORMULATION RESISTANT TO ALCOHOL INDUCED DOSE DUMPING Dr. Dieter Lubda MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany Agenda: Sustained release
More informationAdvantages and Limitations of In Vivo Predictive Dissolution (IPD) Systems
Advantages and Limitations of In Vivo Predictive Dissolution (IPD) Systems November 16 th Prof. Gregory E. Amidon - University of Michigan What is an In vivo Predictive Dissolution (IPD) System? An IPD
More informationLYCOAT. New solutions for Film Coating from Roquette. LYCOAT for quicker quality coating
LYCOAT New solutions for Film Coating from Roquette LYCOAT for quicker quality coating Roquette LYCOAT New solutions for Film Coating from Roquette LYCOAT New solutions for Film Coating Film coating, the
More informationDEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED RELEASE FLOATING MATRIX TABLETS OF METFORMIN HYDROCHLORIDE
ISSN: 0975-8232 IJPSR (2010), Vol. 1, Issue 8 (Research article) Received 11 April, 2010; received in revised form 17 June, 2010; accepted 13 July, 2010 DEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED
More informationCHAPTER 8 HYDROGEL PLUG FORMULATION AND EVAUATION
CHAPTER 8 HYDROGEL PLUG FORMULATION AND EVAUATION 8.1 Preparation of erodible tablet plug (Hydrogel Plug) Direct compression method was used to prepare the erodible tablet plug. The compositions of different
More informationAdvantages and Limitations of In Vivo Predictive Dissolution (IPD) Systems
Advantages and Limitations of In Vivo Predictive Dissolution (IPD) Systems November 16 th Prof. Gregory E. Amidon - University of Michigan What is an In vivo Predictive Dissolution (IPD) System? An IPD
More informationJournal of Chemical and Pharmaceutical Research
Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(3):159-164 Studies on formulation and in vitro evaluation
More informationDextrol and Strodex Surfactant Selection Guide
Dextrol and Strodex Surfactant Selection Guide Complete solutions for coatings Dextrol and Strodex phosphate ester surfactants from Ashland Aqualon Functional Ingredients are leading technologies within
More informationEastman cellulose esters Pharmaceutical applications and drug delivery
Eastman cellulose esters Pharmaceutical applications and drug delivery Cellulose esters are part of a large family of cellulose derivatives that have a long history of use in pharmaceutical applications.
More informationPreparation and Evaluation of Gastro Retentive Floating Tablets of Atorvastatin Calcium
Preparation and Evaluation of Gastro Retentive Floating Tablets of Atorvastatin Calcium Florida Sharmin 1, Md. Abdullah Al Masum 1, S. M. Ashraful Islam 1 and Md. Selim Reza 2 1 Department of Pharmacy,
More informationVolume: 2: Issue-3: July-Sept ISSN FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF NICORANDIL
Volume: 2: Issue-3: July-Sept -2011 ISSN 0976-4550 FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF NICORANDIL Ajaykumar Patil*, Ashish Pohane, Ramya Darbar, Sharanya Koutika, Alekhya
More informationDesign and In-vitro Evaluation of Silymarin Bilayer Tablets
CODEN (USA)-IJPRUR, e-issn: 2348-6465 International Journal of Pharma Research and Health Sciences Available online at www.pharmahealthsciences.net Original Article Design and In-vitro Evaluation of Silymarin
More informationNon-Food Uses of Polysaccharides
Non-Food Uses of Polysaccharides John Mitchell John.Mitchell@biopolymersolutions.co.uk Acknowledgements Fundamentals of Hydrocolloid Technology Course (2003-2009) Rob Winwood Colin Melia Steve Harding
More informationENHANCEMENT OF SOLUBILITY OF BICALUTAMIDE DRUG USING SOLID DISPERSION TECHNIQUE
PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES ENHANCEMENT OF SOLUBILITY OF BICALUTAMIDE DRUG USING SOLID DISPERSION TECHNIQUE Kantilal B. Narkhede *1, R. B. Laware 2, Y. P.
More informationFormulation and Development of Sustained Release Tablets of Valsartan Sodium
INTERNATIONAL JOURNAL OF ADVANCES IN PHARMACY, BIOLOGY AND CHEMISTRY Research Article Formulation and Development of Sustained Release Tablets of Valsartan Sodium G. Sandeep * and A. Navya Department of
More informationBahadur S. et al /J. Pharm. Sci. & Res. Vol.1(4), 2009,
Abstract: In the present work, we developed an effective mucoadhesive tablets of omeprazole(diomeprazole magnesium powder and omeprazole pellets) by direct punch method with excellent mucoadhesive force
More informationBioavailability enhancement of poorly soluble APIs. Enhanced solubilization out of solid glassy solutions prepared by Hot-Melt Extrusion
Pharma Ingredients & Services. Welcome to more opportunities. Custom Synthesis Excipients Active Ingredients ExActConcepts Example: Itraconazole Bioavailability enhancement of poorly soluble APIs Enhanced
More informationEUDRAGIT E 100, EUDRAGIT E PO and
Technical Information EUDRAGIT E 100, and Specification and Test Methods Ph. Eur. USP/NF JPE Basic Butylated Methacrylate Copolymer Amino Methacrylate Copolymer - NF Aminoalkyl Methacrylate Copolymer E
More informationTECHNICAL INFORMATION RxCIPIENTS FM A versatile excipient for orally disintegrating tablet (ODT) formulations
TECHNICAL INFORMATION 1426 RxCIPIENTS FM 1 A versatile excipient for orally disintegrating tablet (ODT) formulations Table of contents 1 Introduction 3 2 Mode of action and advantages of RxCIPIENTS FM
More informationFormulation and In-vitro Evaluation of Chewable Tablets of Montelukast Sodium
Available online on www.ijddt.com International Journal of Drug Delivery Technology 214; (3); 98-13 Research Article ISSN: 97 441 Formulation and In-vitro Evaluation of Chewable Tablets of Montelukast
More informationEUDRAGIT L 100 and EUDRAGIT S 100
Technical Information EUDRAGIT L 100 and EUDRAGIT S 100 Specification and Test Methods Ph. Eur. Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)
More informationFORMULATION AND EVALUATION OF PIROXICAM AND CELECOXIB TABLETS EMPLOYING PROSOLVE BY DIRECT COMPRESSION METHOD
Int. J. Chem. Sci.: 6(3), 2008, 1270-1275 FORMULATION AND EVALUATION OF PIROXICAM AND CELECOXIB TABLETS EMPLOYING PROSOLVE BY DIRECT COMPRESSION METHOD K. P. R. CHOWDARY, P. TRIPURA SUNDARI and K. SURYA
More informationExcipient Quality & Trouble Shooting. By Seema Trivedi GM, Technical
Excipient Quality & Trouble Shooting By Seema Trivedi GM, Technical Back Ground The Society for Pharmaceutical Dissolution Science (SPDS) had held its 6th Annual International Convention Disso India -
More informationA study of compressibility and compactibility of directly compressible tableting materials containing tramadol hydrochloride
Acta Pharm. 66 (2016) 433 441 DOI: 10.1515/acph-2016-0034 Short communication A study of compressibility and compactibility of directly compressible tableting materials containing tramadol hydrochloride
More informationSTUDIES ON EFFECT OF BINDERS ON ETORICOXIB TABLET FORMULATIONS
Int. J. Chem. Sci.: 10(4), 2012, 1934-1942 ISSN 0972-768X www.sadgurupublications.com STUDIES ON EFFECT OF BINDERS ON ETORICOXIB TABLET FORMULATIONS K. VENUGOPAL * and K. P. R. CHOWDARY a Nirmala College
More informationInternational Journal of Medicine and Pharmaceutical Research
International Journal of Medicine and Pharmaceutical Research Journal Home Page: www.pharmaresearchlibrary.com/ijmpr Research Article Open Access Formulation and Evaluation of Gastroretentive Floating
More informationMODULATION OF GASTROINTESTINAL TRANSIT TIME OF SALBUTAMOL SULPHATE BY FLOATING APPROCHES
Pooja et al Journal of Drug Delivery & Therapeutics; 213, 3(3), 37-41 37 Available online at http://jddtonline.info RESEARCH ARTICLE MODULATION OF GASTROINTESTINAL TRANSIT TIME OF SALBUTAMOL SULPHATE BY
More informationEffect of Polymer Concentration and Viscosity Grade on Atenolol Release from Gastric Floating Drug Delivery Systems
Effect of Polymer Concentration and Viscosity Grade on Atenolol Release from Gastric Floating Drug Delivery Systems 1 1 1 2 U.V. Bhosale*, V. Kusum Devi, Nimisha Jain and P.V. Swamy 1 Al-Ameen College
More informationPreparation and In vitro Evaluation of Mucoadhesive Tablets of Montelukast Sodium
Bangladesh Pharmaceutical Journal 20(2): 123-131, 2017 Preparation and In vitro Evaluation of Mucoadhesive Tablets of Montelukast Sodium Farzana Akter Bithi, Tushar Saha, Nusrat Ahmed, Ikramul Hasan and
More informationBiopharmaceutics Dosage form factors influencing bioavailability Lec:5
Biopharmaceutics Dosage form factors influencing bioavailability Lec:5 Ali Y Ali BSc Pharmacy MSc Industrial Pharmaceutical Sciences Dept. of Pharmaceutics School of Pharmacy University of Sulaimani 09/01/2019
More informationFORMULATION AND EVALUATION OF BILAYERED TABLET OF METFORMIN HYDROCHLORIDE AND GLIMEPIRIDE
Research Article Ghanshyam Patel,, 2012; Volume 1(6): 75-87 ISSN: 2277-8713 FORMULATION AND EVALUATION OF BILAYERED TABLET OF METFORMIN HYDROCHLORIDE AND GLIMEPIRIDE -QR CODE GHANSHYAM PATEL 1, Dr. RAGIN
More informationPHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY
PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY Excipients are inactive ingredients used as carriers for the active ingredients in a pharmaceutical product. These may
More informationKolliwax HCO. Technical Information. Hydrogenated castor oil powder for pharmaceutical use. = Registered trademark in many countries.
Technical Information Kolliwax HCO September 2015 03_150617e_00/Page 1 of 8 WF-No. 129938 = Registered trademark in many countries Hydrogenated castor oil powder for pharmaceutical use 03_150617e_00 September
More informationApplication of IVIVCs in Formulation Development Douglas F Smith
Application of IVIVCs in Formulation Development Douglas F Smith PQRI Workshop on Application of IVIVC in Formulation Development September 5-6, 2012 Bethesda, Maryland In Vitro/In Vivo Correlations -
More informationAsian Journal of Research in Biological and Pharmaceutical Sciences
Research Article ISSN: 2349 4492 Asian Journal of Research in Biological and Pharmaceutical Sciences Journal home page: www.ajrbps.com APPLICATION OF FACTORIAL DESIGN AND OPTIMIZATION OF GLIMEPIRIDE SUSTAINED
More informationJournal of Chemical and Pharmaceutical Research
Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 211, 3(2):786-791 Development and optimization of colon targeted
More informationDesign and Evaluation of Atenolol Floating Drug Delivery System
Available online on www.ijcpr.com International Journal of Current Pharmaceutical Review and Research, 4(1), 1-26 Research Article ISSN: 976-822X Design and Evaluation of Atenolol Floating Drug Delivery
More informationEVALUATION OF EFFERVESCENT FLOATING TABLETS. 6.7 Mathematical model fitting of obtained drug release data
EVALUATION OF EFFERVESCENT FLOATING TABLETS 6.1 Technological characteristics of floating tablets 6.2 Fourier transform infrared spectroscopy (FT-IR) 6.3 Differential scanning calorimetry (DSC) 6.4 In
More informationFormulation and In vitro Release Characterization of Metoprolol Succinate Extended Release Tablets
Sakthikumar et al: Formulation and In vitro Release Characterization of Metoprolol Succinate Extended Release Tablets 1537 International Journal of Pharmaceutical Sciences and Nanotechnology Volume 4 Issue
More informationLubriTose Mannitol Michael Crowley, Director of R&D, Excipients
LubriTose Mannitol Michael Crowley, Director of R&D, Excipients Introduction Michael Crowley Director of R&D Excipients 158 St. Highway 320 Norwich, NY 13815 PH 315-802-5970 Michael.Crowley@Kerry.com 2
More informationDesign development and evaluation of citicoline controlled release tablets
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2013, 5 (1):296-311 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationLarge scale production
Large scale production Rotary capsule machine: This machine has two, side-by-side cylinders in each of which half-moulds are cut. These cylinders, like the rollers of a mangle, rotate in contrary direction
More information( 12 ) Patent Application Publication ( 10 ) Pub. No.: US 2017 / A1
THE LETTERIN US 20170231969A1 MUTTU 19 United States ( 12 ) Patent Application Publication ( 10 ) Pub. No.: US 2017 / 0231969 A1 Raneburger et al. ( 43 ) Pub. Date : Aug. 17, 2017 ( 54 ) PHARMACEUTICAL
More informationVirendra Singh et.al, IJPRR 2014; 3(11) 22
Research Article Formulation and Development of Sustained Release Matrix Tablet of Ranolazine *Virendra Singh, Lokesh Kumar, Rakesh Kumar Meel Department of Pharmaceutics, Goenka College of Pharmacy, Vill.
More informationDow Wolff Cellulosics. Using ingenuity and savvy. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow
Dow Wolff Cellulosics Pharmaceutical Excipients Using ingenuity and savvy to help design healthcare solutions TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Enhancing
More informationExperiences with USP Apparatus 4 Calibration
Experiences with USP Apparatus 4 Calibration Johannes Krämer 1,2, and Erika Stippler 1 email: jkraemer@phast.de Table 1. List of participating laboratory of the 1 st Collaborative Study Laboratory code
More informationDevelopment and Evaluation of Press Coated Tablet of Aceclofenac Shinde PV* and Mayee RV
Development and Evaluation of Press Coated Tablet of Aceclofenac Shinde PV* and Mayee RV Department of pharmaceutical sciences, Shri Jagdish Prasad Jhabarmal Tibrewala University Abstract The objective
More informationOptimization of Glipizide sustained release matrix tablet formulation by central composite design- response surface methodology
Research Article Optimization of Glipizide sustained release matrix tablet formulation by central composite design- response surface methodology Parasuram Rajam Radhika* 1, Tapan kumar Pal 1, Thangavel
More informationDirect Compression Formulation Using Starch 1500 with Ranitidine HCl (150 mg) Tablets, Film Coated with Opadry II (85F Series)
Technical Data Direct Compression Ranitidine Formulation Direct Compression Formulation Using Starch 15 with Ranitidine HCl (15 mg) Tablets, Film Coated with Opadry II (5F Series) INTRODUCTION Ranitidine
More informationPQRI Workshop Bethesda 2012
Review of GI physiology and use of biorelevant media PQRI Workshop Bethesda 2012 Prof. Dr. Jennifer Dressman An IVIVC can only be as good as the data used to produce it! With respect to the dissolution
More informationPatel Krunal M et al. IRJP 2 (2)
INTERNATIONAL RESEARCH JOURNAL OF PHARMACY ISSN 223 87 Available online http://www.irjponline.com Research Article DESIGN DEVELOPMENT AND EVALUATION OF MODIFIED RELEASE TABLET OF MONTELUKAST SODIUM BY
More informationPREPARATION AND INVITRO EVALUATION OF RABEPRAZOLE SODIUM DELAYED RELEASE ENTERIC COATED TABLETS
Page1000 Indo American Journal of Pharmaceutical Research, 2014 ISSN NO: 2231-6876 Journal home page: http:///index.php/en/ INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH PREPARATION AND INVITRO EVALUATION
More informationFormulation and evaluation of sustained release atenolol
9 Formulation, optimization and evaluation of sustained release layer of atenolol Atenolol is a cardioselective β-blocker widely prescribed for asymptomatic condition such as hypertension. It is poorly
More informationFormulation and In-vitro Evaluation of Sumatriptan succinate Bilayer Tablets
Formulation and In-vitro Evaluation of Sumatriptan succinate Bilayer Tablets M. Sunitha Reddy 1, B. Sharath Reddy 1, S. Muhammed Fazal Ul Haq 1 Centre of Pharmaceutical Sciences, Jawaharlal Nehru Technological
More informationInternational Journal of Innovative Pharmaceutical Sciences and Research
International Journal of Innovative Pharmaceutical Sciences and Research www.ijipsr.com FORMULATION AND EVALUATION OF ph INDEPENDENT TABLETS OF ATENOLOL 1 S. Mahaboob Basha*, 2 N. Srinivas Department of
More informationCool Solutions for Hot Flushes
Cool Solutions for Hot Flushes The use of Coated Minitablets to achieve a Flexible Release Profile for Gabapentin Mark Powell Scientific Manager Quay Pharmaceuticals Project Outline Gabapentin is an established
More informationFORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels
Seite 1 von 8 Share this story: Issue: April 2015, Posted Date: 3/30/2015 FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels INTRODUCTION Soft gelatin capsules (softgels) continue
More informationFORMULATION AND EVALUATION OF GASTRORETENTIVE FLOATING TABLETS OF FAMOTIDINE
FORMULATION AND EVALUATION OF GASTRORETENTIVE FLOATING TABLETS OF FAMOTIDINE Chandira. Margret R. *, Sahu Chandra Mohan and Jayakar B. Vinayaka Mission s College of Pharmacy Vinayaka Missions University,
More informationChallenges in Developing Stable and Efficient Probiotic Formulations
Challenges in Developing Stable and Efficient Probiotic Formulations Morgan Laloux morgan.laloux@capsugel.com +32 491 73 20 53 Summary Challenges in Formulating Probiotics Formulating Probiotics in Capsules
More informationANNEXURE -2. Excipients profiles of Compritol ATO 888, Gelucire 43/01, HPMC and PVP and have been described in the following section.
2. EXCIPIENTS PROFILES ANNEXURE -2 Excipients profiles of Compritol ATO 888, Gelucire 43/01, HPMC and PVP and have been described in the following section. 2.1. COMPRITOL 888 Non proprietary names BP:
More informationEP A1 (19) (11) EP A1 (12) EUROPEAN PATENT APPLICATION. (43) Date of publication: Bulletin 2010/39
(19) (12) EUROPEAN PATENT APPLICATION (11) EP 2 233 131 A1 (43) Date of publication: 29.09. Bulletin /39 (1) Int Cl.: A61K 9/ (06.01) A61K 31/00 (06.01) (21) Application number: 09908.8 (22) Date of filing:
More informationJournal of Chemical and Pharmaceutical Research
Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2010, 2(4):993-998 Formulation and evaluation of Prednisolone
More informationCompliance. Should you have any questions, please contact Behnaz Almasi, Associate Scientific Liaison ( or
Extended-Release Tablets Type of Posting Revision Bulletin Posting Date 30 Mar 2018 Official Date 01 Apr 2018 Expert Committee Chemical Medicines Monographs 3 Reason for Revision Compliance In accordance
More informationRESEARCH ARTICLE. Darshanwar Varun.S.*,Jadhav S.B. Hambarde. S.K.
RESEARCH ARTICLE ISSN: 2348-8948 Vol: 3; Issue: 7 DEVELOPMENT AND EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM OF DILTIAZEM HYDROCHLORIDE Darshanwar Varun.S.*,Jadhav S.B. Hambarde. S.K. Department of Pharmaceutics,
More informationSivakasi , Tamil Nadu, India. ABSTRACT KEYWORDS:
276 P a g e International Standard Serial Number (ISSN): 2319-8141 International Journal of Universal Pharmacy and Bio Sciences 4(1): January-February 2015 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND
More informationFORMULATION AND EVALUATION OF DILTIAZEM HYDROCHLORIDE COLON TARGETED TABLETS
INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY Available online at www.ijrpc.com Research Article FORMULATION AND EVALUATION OF DILTIAZEM HYDROCHLORIDE COLON TARGETED TABLETS G. Subba Rao
More information